Notice2023-28111
Medicare and Medicaid Programs; Application From The Compliance Team (TCT) for Continued Approval of its Rural Health Clinics Program
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Published
December 21, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed notice acknowledges the receipt of an application from the Compliance Team (TCT) for continued recognition as a national accrediting organization (AO) for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Full Text
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<title>Federal Register, Volume 88 Issue 244 (Thursday, December 21, 2023)</title>
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[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88393-88395]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3455-PN]
Medicare and Medicaid Programs; Application From The Compliance
Team (TCT) for Continued Approval of its Rural Health Clinics Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice with request for comment.
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SUMMARY: This proposed notice acknowledges the receipt of an
application from the Compliance Team (TCT) for continued recognition as
a national accrediting organization (AO) for Rural Health Clinics
(RHCs) that wish to participate in the Medicare or Medicaid programs.
The statute requires that within 60 days of receipt of an
organization's complete application, the Centers for Medicare &
Medicaid Services (CMS) publish a notice that identifies the national
accrediting body making the request, describes the nature of the
request, and provides at least a 30-day public comment period.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by January 22, 2024.
ADDRESSES: In commenting, refer to file code CMS-3455-PN.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3455-PN, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for
[[Page 88394]]
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-3455-PN, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Joy Webb (410) 786-1667.
Shonte Carter (410) 786-3532.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. We will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. We
continue to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a Medicare-participating Rural Health Clinic
(RHC), provided certain requirements are met. Sections 1861(aa)(1) and
(2) and 1905(l)(1) of the Social Security Act (the Act) establish
distinct criteria for an entity seeking designation as an RHC.
Regulations concerning provider agreements are at 42 CFR part 489, and
those pertaining to activities relating to the survey and certification
of facilities and other entities are at 42 CFR part 488. The
regulations at 42 CFR part 491 specify the conditions that a RHC must
meet to participate in the Medicare program.
Generally, to enter into an agreement, a RHC must first be
certified by a State survey agency as complying with the conditions or
requirements set forth in part 491 of our regulations. Thereafter, the
RHC is subject to regular surveys by a State survey agency to determine
whether it continues to meet these requirements.
However, there is an alternative to surveys by State agencies.
Section 1865(a)(1) of the Act provides that if a provider entity
demonstrates through accreditation by a Center for Medicare & Medicaid
Services (CMS) approved national accrediting organization (AO) that all
applicable Medicare conditions are met or exceeded, we will deem those
provider entities as having met the requirements. Accreditation by an
AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of Health and Human
Services (the Secretary) as having standards for accreditation that
meet or exceed Medicare requirements, any provider entity accredited by
the national accrediting body's approved program would be deemed to
meet the Medicare conditions. A national AO applying for approval of
its accreditation program under 42 CFR part 488, subpart A must provide
CMS with reasonable assurance that the AO requires the accredited
provider entities to meet requirements that are at least as stringent
as the Medicare conditions. Our regulations concerning the approval of
AO are set forth at Sec. 488.4 and 488.5. The regulations at Sec.
488.5(e)(2)(i) require AOs to reapply for continued approval of their
accreditation program every 6 years or sooner as determined by CMS.
The Compliance Team's (TCT's) term of approval for their RHC
accreditation program expires July 17, 2024.
II. Approval of Deeming Organization
Section 1865(a)(2) of the Act and our regulations at Sec. 488.5
require that our findings concerning review and approval of a national
AO's requirements consider, among other factors, the applying AO's
requirements for accreditation; survey procedures; resources for
conducting required surveys; capacity to furnish information for use in
enforcement activities; monitoring procedures for provider entities
found not in compliance with the conditions or requirements; and
ability to provide us with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish,
within 60 days of receipt of an organization's complete application, a
notice identifying the national accrediting body making the request,
describing the nature of the request, and providing at least a 30-day
public comment period. We have 210 days from the receipt of a complete
application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of
TCT's request for continued approval for its RHC accreditation program.
This notice also solicits public comment on whether TCT's requirements
meet or exceed the Medicare conditions for certification (CfCs) for
RHCs.
III. Evaluation of Deeming Authority Request
TCT submitted all the necessary materials to enable us to make a
determination concerning its request for continued approval of its RHC
accreditation program. This application was determined to be complete
on October 25, 2023. Under section 1865(a)(2) of the Act and our
regulations at Sec. 488.5 (Application and re-application procedures
for national accrediting organizations), our review and evaluation of
TCT will be conducted in accordance with, but not necessarily limited
to, the following factors:
<bullet> The equivalency of TCT's standards for RHCs as compared
with CMS' RHC CfCs.
<bullet> TCT's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and
the ability of the organization to provide continuing surveyor
training.
++ The comparability of TCT's processes to those of State agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited RHCs.
++ TCT's processes and procedures for monitoring RHCs found out of
compliance with TCT's program requirements. These monitoring procedures
are used only when TCT identifies noncompliance. If noncompliance is
identified through validation reviews or complaint surveys, the State
survey agency monitors corrections as specified at Sec. 488.9(c).
++ TCT's capacity to report deficiencies to the surveyed RHCs and
respond to the RHC's plan of correction in a timely manner.
++ TCT's capacity to provide us with electronic data and reports
necessary for effective validation and assessment of the organization's
survey process.
++ The adequacy of TCT's staff and other resources, and its
financial viability.
++ TCT's capacity to adequately fund required surveys.
++ TCT's policies with respect to whether surveys are announced or
unannounced, to assure that surveys are unannounced.
++ TCT's policies and procedures to avoid conflicts of interest,
including the appearance of conflicts of interest, involving
individuals who conduct surveys or participate in accreditation
decisions.
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++ TCT's agreement to provide us with a copy of the most current
accreditation survey together with any other information related to the
survey as we may require (including corrective action plans).
IV. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the ``DATES'' section of this
preamble, and when we proceed with a subsequent document, we will
respond to the comments in the preamble to that document.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-28111 Filed 12-20-23; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on December 21, 2023.
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